Dataset Information

Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial.

ABSTRACT:

Objectives

To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.

Design

Open, multicentre, randomised, controlled, non-inferiority trial.

Setting

Seven National Health Service tertiary hospitals in the United Kingdom.

Participants

1905 elective surgical inpatients (?18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.

Intervention

Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.

Outcome measures

The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.

Results

Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.

Conclusions

For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.

Trial registration

ISRCTN13911492.

SUBMITTER: Shalhoub J

PROVIDER: S-EPMC7219517 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial.

Shalhoub Joseph J Lawton Rebecca R Hudson Jemma J Baker Christopher C Bradbury Andrew A Dhillon Karen K Everington Tamara T Gohel Manjit S MS Hamady Zaed Z Hunt Beverley J BJ Stansby Gerrard G Warwick David D Norrie John J Davies Alun H AH

BMJ (Clinical research ed.) 20200513

<h4>Objectives</h4>To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.<h4>Design</h4>Open, multicentre, randomised, controlled, non-inferiority trial.<h4>Setting</h4>Seven National Health Service tertiary hospitals in the United Kingdom.<h4>Participants</h4>1905 elective surgical inpatients (≥18 years) assessed as being at modera ...[more]

PMID: 32404430

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Project description:IntroductionRecommendations for venous thromboembolism and deep venous thrombosis (DVT) prophylaxis using graduated compression stockings (GCS) is historically based and has been critically examined in current publications. Existing guidelines are inconclusive as to recommend the general use of GCS.Patients/Methods: 24 273 in-patients (general surgery and orthopedic patients) undergoing surgery between 2006 and 2016 were included in a retrospectively analysis from a single center. From January 2006 to January 2011 perioperative GCS was employed additionally to drug prophylaxis and from February 2011 to March 2016 patients received drug prophylaxis alone. According to german guidelines all patients received venous thromboembolism prophylaxis with weight-adapted LMWH. Risk stratification (low risk, moderate risk, high risk) was based on the guideline of the American College of Chest Physicians. Data analysis was performed before and after propensity matching (PM). The defined primary endpoint was the incidence of symptomatic or fatal pulmonary embolism (PE). A secondary endpoint was the incidence of deep venous thromboembolism (DVT).ResultsAfter risk stratification (low risk n = 16 483; moderate risk n = 4464; high risk n = 3326) a total of 24 273 patient were analyzed. Before to PM the relative risk for the occurrence of a PE or DVT was not increased by abstaining from GCS. After PM two groups of 11 312 patients each, one with and one without GCS application, were formed. When comparing the two groups, the relative risk (RR) for the occurrence of a pulmonary embolism was: Low Risk 0.99 [CI95% 0.998-1.000]; Moderate Risk 0.999 [CI95% 0.95-1.003]; High Risk 0.996 [CI95% 0.992-1.000] (p > 0.05). The incidence of PE in the total group LMWH alone was 0.1% (n = 16). In the total group using LMWH + GCS, the incidence was 0.3% (n = 29). RR after PM was 0.999 [CI95% 0.998-1.00].ConclusionIn comparison to prior studies with only small numbers of patients our trial shows in a large group of patients with moderate and high risk developing VTE we can support the view that abstaining from GCS-use does not increase the incidence of symptomatic or fatal PE and symptomatic DVT.

Project description:BackgroundPost-operative limb swelling may negatively affect the outcome of arthroscopic surgery and prolong rehabilitation. The aim of this pilot study was to evaluate the effect of compression stockings versus no compression on post-operative swelling and pain in the early post-operative phase.MethodsA single-centre, randomised controlled trial was performed. Patients who underwent minor knee arthroscopy were randomised to wear class II compression stockings (23-32 mmHg) (CS) or no compression stockings (NCS) immediately post-operatively for ten days. All patients received low molecular weight heparin (LMWH) at prophylactic dosage. The primary outcome variable was post-operative swelling of the limb, quantified by using an optical 3D measurement system (Bodytronic© 600). Pain was rated on a visual analogue scale (VAS). From a total of 76 patients assessed, 19 patients were eligible for final analysis. The trial followed the CONSORT criteria, was registered at clinicaltrial.gov and approved by the local ethics committee.ResultsThe circumference at the middle thigh (cF) was significantly different between groups at day 10 (p = 0.032; circumference - 1.35 ± 2.15% (CS) and + 0.79 ± 3.71% (NCS)). Significant differences were also noted around the knee (cD) at day 10 (p = 0.026) and a significant trend at cD and at the mid lower leg (cB1) at day 4. The volume of the thigh was also different with marked difference between days 1 and 4 between the two groups (p = 0.021; volume + 0.54 ± 2.03% (CS) and + 4.17 ± 4.67 (NCS)). Pain was lower in compression group (not statistically significant).ConclusionsPost-operative limb swelling can be reduced significantly by wearing compression stockings in the early post-operative phase when compared to not wearing stockings. This may improve the rehabilitation process after arthroscopic surgery. The optimal duration of compression therapy seems to be between three and ten days.Trial registrationclinicaltrials.gov ( NCT02096562 , date of registration 11.11.2013).

Project description:BackgroundVenous thromboembolism (VTE) is a serious, sometimes life-threatening complication that can occur following spine surgery. The incidence of VTE, and the optimal type and timing of thromboprophylaxis for this complication in elective spine surgery is a matter of debate.ObjectiveTo perform a systematic review with the aim of clarifying the efficacy and adverse effects of mechanical and chemical prophylaxis for preventing thromboembolic complications in elective spine surgery for conditions other than trauma and malignant disease.Methods/designA search strategy of related articles up to March 2018 was designed and executed in Medline and Embase.Patientsadolescents (>10 years) and adults undergoing elective surgery for spinal deformity or degenerative disease (from C1 to S1).InterventionPerioperative mechanical and chemical thromboprophylaxis. Studies could be randomized controlled trials or observational studies that reported data on any relevant clinical outcomes.ResultsIn total, 2451 uniquecitations were identified and 35 studies were ultimately included in the systematic review. The overall mean incidence of complications was 3.7% for deep venous thrombosis, 0.0% for pulmonary embolism, and 3.7% for bleeding in chemoprophylaxis group; 2.9% for deep venous thrombosis, 0.4% for pulmonary embolism and 0.0% for bleeding in mechanoprophylaxis; and 0.7% for deep venous thrombosis, 0.1% for pulmonary embolism and 0.2% for bleeding in mixed prophylaxis group with no specific data on these rates for the type of patient and type and location of surgery. None of the articles retrieved provided information on the adolescent population.Discussion and conclusionsThe poor design and high variability among the studies regarding characteristics of study population, details of interventions, and definitions of outcomes, determines a low quality of the available evidence and limits the interpretation of the results. We were unable to identify a clear advantage of one type of thromboprophylaxis over the other, although there was an increased risk of bleeding with chemoprophylaxis, which could favor the use of mechanoprophylaxis in this scenario.

Dataset Information

Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial.

Objectives

Design

Setting

Participants

Intervention

Outcome measures

Results

Conclusions

Trial registration

Publications

Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial.

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